Mode of delivery of Cognitive Behavioral Therapy for Insomnia: a randomized controlled non-inferiority trial of digital and face-to-face therapy.

Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) has demonstrated efficacy in reducing insomnia severity in self-referred and community samples. It is unknown, however, how dCBT-I compares to individual face-to-face (FtF) CBT-I for individuals referred to clinical secondary services. We undertook a randomized controlled trial to test whether fully automated dCBT-I is non-inferior to individual FtF CBT-I in reducing insomnia severity. Eligible participants were adult patients with a diagnosis of insomnia disorder recruited from a sleep clinic provided via public mental health services in Norway. The Insomnia Severity Index (ISI) was the primary outcome measure. The non-inferiority margin was defined a priori as 2.0 points on the ISI at week 33. Individuals were randomized to FtF CBT-I (n = 52) or dCBT-I (n = 49); mean baseline ISI scores were 18.4 (SD 3.7) and 19.4 (SD 4.1), respectively. At week 33, the mean scores were 8.9 (SD 6.0) and 12.3 (SD 6.9), respectively. There was a significant time effect for both interventions (p < 0.001); and the mean difference in ISI at week 33 was -2.8 (95% CI: -4.8 to -0.8; p = 0.007, Cohen's d = 0.7), and -4.6 at week 9 (95% CI -6.6 to -2.7; p < 0.001), Cohen's d = 1.2. At the primary endpoint at week 33, the 95% CI of the estimated treatment difference included the non-inferiority margin and was wholly to the left of zero. Thus, this result is inconclusive regarding the possible inferiority or non-inferiority of dCBT-I over FtF CBT-I, but dCBT-I performed significantly worse than FtF CBT-I. At week 9, dCBT-I was inferior to FtF CBT-I as the 95% CI was fully outside the non-inferiority margin. These findings highlight the need for more clinical research to clarify the optimal application, dissemination, and implementation of dCBT-I. Clinicaltrials.gov: NCT02044263: Cognitive Behavioral Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Non-inferiority Trial.

Kallestad H ，Scott J ，Vedaa Ø ，Lydersen S ，Vethe D ，Morken G ，Stiles TC ，Sivertsen B ，Langsrud K ... -  《-》

Effects of digital cognitive behavioural therapy for insomnia on insomnia severity: a large-scale randomised controlled trial.

Although several large-scale randomised controlled trials have shown the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I), there is a need to validate widespread dissemination of dCBT-I using recommended key outcomes for insomnia. We investigated the effect of a fully automated dCBT-I programme on insomnia severity, sleep-wake patterns, sleep medication use, and daytime impairment. We did a parallel-group superiority randomised controlled trial comparing dCBT-I with online patient education about sleep. The interventions were available through a free-to-access website, publicised throughout Norway, which incorporated automated screening, informed consent, and randomisation procedures, as well as outcome assessments. Adults (age ≥18 years) who had regular internet access and scored 12 or higher on the Insomnia Severity Index (ISI) were eligible for inclusion, and were allocated (1:1) to receive dCBT-I (consisting of six core interactive sessions to be completed over 9 weeks) or patient education (control group). Participants were masked to group assignment and had no contact with researchers during the intervention period. The primary outcome was the change in ISI score from baseline to 9-week follow-up, assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov (NCT02558647) and is ongoing, with 2-year follow-up assessments planned. Between Feb 26, 2016, and July 1, 2018, 5349 individuals commenced the online screening process, of which 1497 were ineligible or declined to participate, 2131 discontinued the screening process, and 1721 were randomly allocated (868 to receive dCBT-I and 853 to receive patient education). At 9-week follow-up, 584 (67%) participants in the dCBT-I group and 534 (63%) in the patient education group completed the ISI assessment. The latent growth model showed that participants in the dCBT-I group had a significantly greater reduction in ISI scores from baseline (mean score 19·2 [SD 3·9]) to 9-week follow-up (10·4 [6·2]) than those in the patient education group (from 19·6 [4·0] to 15·2 [5·3]; estimated mean difference -4·7 (95% CI -5·4 to -4·1; Cohen's d -1·21; p<0·001). Compared with patient education, the number needed to treat with dCBT-I was 2·7 (95% CI 2·4 to 3·2) for treatment response (ISI score reduction ≥8) and 3·2 (2·8 to 3·8) for insomnia remission (ISI score <8). No adverse events were reported to the trial team. dCBT-I is effective in reducing the severity of symptoms associated with the insomnia disorder. These findings support the widespread dissemination of dCBT-I. Future research is needed to identify the moderators of response and to improve targeting. Norwegian Research Council; Liaison Committee for Education, Research and Innovation in Central Norway.

Vedaa Ø ，Kallestad H ，Scott J ，Smith ORF ，Pallesen S ，Morken G ，Langsrud K ，Gehrman P ，Thorndike FP ，Ritterband LM ，Harvey AG ，Stiles T ，Sivertsen B ... -  《The Lancet Digital Health》

Efficacy of digital cognitive behavioural therapy for insomnia: a meta-analysis of randomised controlled trials.

Although cognitive behavioural therapy for insomnia (CBT-I) has been recommended the initial therapy for insomnia, its clinical usage remains limited due to the lack of therapists. Digital CBT-I (dCBT-I) can potentially circumvent this problem. This meta-analysis aims to evaluate the short-term and long-term efficacy of dCBT-I for adults with insomnia. Systematic search of PubMed, EMBASE, PsycINFO, and CENTRAL from inception till 5 March 2020 was conducted. Randomised controlled trials (RCTs) comparing dCBT-I with controls (wait-list/treatment-as-usual/online education) in adults with insomnia were eligible. The primary outcome was insomnia severity index (ISI) at post-intervention, short-term follow-up (ranging 4 weeks to 6 months) and 1-year follow-up. Mean differences were pooled using the random-effects model. 94 articles were assessed full-text independently by two team members and 33 studies were included in this meta-analysis. 4719 and 4645 participants were randomised to dCBT-I and control respectively. dCBT-I significantly reduces ISI at post-intervention with mean difference -5.00 (95% CI -5.68 to -4.33, p < 0.0001) (I2 = 79%) compared to control. The improvements were sustained at short-term follow-up, -3.99 (95% CI -4.82 to -3.16, p < 0.0001) and 1-year follow-up, -3.48 (95% CI -4.21 to -2.76, p < 0.0001). Compared to dCBT-I, face-to-face CBT-I produced greater improvement in ISI, 3.07 (95% CI 1.18 to 4.95, p = 0.001). However, this was within the non-inferiority interval of 4 points on ISI. This meta-analysis provides strong support for the effectiveness of dCBT-I in treating insomnia. dCBT-I has potential to revolutionise the delivery of CBT-I, improving the accessibility and availability of CBT-I content for insomnia patients worldwide.

Soh HL ，Ho RC ，Ho CS ，Tam WW ... -  《-》

Investigating non-inferiority of internet-delivered versus face-to-face cognitive behavioural therapy for insomnia (CBT-I): a randomised controlled trial (iSleep well).

Insomnia is a highly prevalent disorder associated with numerous adverse health outcomes. Cognitive behavioural therapy for insomnia (CBT-I) is recommended as first-line treatment by clinical guidelines but is accessible to only a minority of patients suffering from insomnia. Internet-delivered CBT-I (iCBT-I) could contribute to the widespread dissemination of this first-line treatment. As there is insufficient evidence regarding non-inferiority, this study directly aims to compare therapist-guided internet-delivered versus face-to-face CBT-I in terms of insomnia severity post-treatment. Furthermore, a health-economic evaluation will be conducted, and potential benefits and disadvantages of therapist-guided iCBT-I will be examined. This study protocol describes a randomised controlled two-arm parallel-group non-inferiority trial comparing therapist-guided iCBT-I with face-to-face CBT-I in routine clinical care. A total of 422 patients with insomnia disorder will be randomised and treated at 16 study centres throughout Germany. Outcomes will be assessed at baseline, 10 weeks after randomisation (post), and 6 months after randomisation (follow-up). The primary outcome is insomnia severity measured using the Insomnia Severity Index. Secondary outcomes include depression-related symptoms, quality of life, fatigue, physical activity, daylight exposure, adverse events related to treatment, and a health-economic evaluation. Finally, potential moderator variables and several descriptive and exploratory outcomes will be assessed (e.g. benefits and disadvantages of internet-delivered treatment). The widespread implementation of CBT-I is a significant healthcare challenge. The non-inferiority of therapist-guided iCBT-I versus face-to-face CBT-I will be investigated in an adequately powered sample in routine clinical care, with the same therapeutic content and same level of therapist qualifications provided with both interventions. If this trial demonstrates the non-inferiority of therapist-guided iCBT-I, healthcare providers may be more confident recommending this treatment to their patients, contributing to the wider dissemination of CBT-I. Trial registration number in the German Clinical Trials Register: DRKS00028153 ( https://drks.de/search/de/trial/DRKS00028153 ). Registered on 16th May 2023.

Benz F ，Grolig L ，Hannibal S ，Buntrock C ，Cuijpers P ，Domschke K ，Ebert DD ，Ell J ，Janneck M ，Jenkner C ，Johann AF ，Josef A ，Kaufmann M ，Koß A ，Mallwitz T ，Mergan H ，Morin CM ，Riemann D ，Riper H ，Schmid SR ，Smit F ，Spille L ，Steinmetz L ，Van Someren EJW ，Spiegelhalder K ，Lehr D ... -  《Trials》

Digital Cognitive Behavioral Therapy for Insomnia Using a Smartphone Application in China: A Pilot Randomized Clinical Trial.

Zhang C ，Liu Y ，Guo X ，Liu Y ，Shen Y ，Ma J ... -  《JAMA Network Open》